The Case of the Day: Can Genes be Patented?

The Case of the Day:     Can Genes be Patented?

Science and The Law go head to head this morning, mano-a-mano, in what we’ll go ahead and call the must-see legal hearing of the day.

The high-profile case involves a challenge to organizations that hold patents covering the BRCA1 and BRCA2 genes, which have been linked to hereditary breast and ovarian cancers. The issue in the case: Whether human genes are subject to patent protection.

The ACLU and others have challenged the BRCA patents on the grounds that they have blocked scientists from conducting necessary testing and research that could yield better and cheaper care for cancer.

Myriad Genetics, which owns the BRCA patents, has countered that patent protection is needed to protect companies that invest considerable time and money developing pioneering genetic tests.

Last year, a New York federal judge struck down some of the BRCA1 and BRCA2 patents, holding that they relate to isolated DNA “found in nature” and thus aren’t subject to patent protection.

An appeal from the case will be heard this morning beginning at 10 a.m. Eastern at the U.S. Court of Appeals for the Federal Circuit.  (Here’s a walk-up to the hearing at the Atlantic and click here to read Law Blog background on the case.)

The Justice Department filed a brief in the case in favor of those challenging the BRCA patents, contending that the “genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible.”

The case has far-reaching implications. As much as 20% of the genome, according to some estimates, is subject to patents, which also cover genetic sequences involving such conditions as hearing loss and Alzheimer’s disease.

As the Atlantic preview of the appeal puts it: “So many people in so many different industries and for so many different reasons are waiting for a ruling in this case from the Federal Circuit – and then perhaps from the United States Supreme Court.”

In separate genetic news, the New York Times today reports on the discovery of no fewer than five genes that promise greater understanding of Alzheimer’s.